For hospitals, the recent introduction of point-of-care (POC) testing capabilities has created unique requirements for secure data transmission from point-of-care test instruments to the central data station (CDS), laboratory information system (LIS), and/or hospital information system (HIS) inventory control.
Point-of-care sample analysis systems are generally based on a reusable reading apparatus that performs sample tests using a disposable device (e.g., a cartridge or strip) that contains analytical elements (e.g., electrodes or optics for sensing analytes such as, for example, pH, oxygen, or glucose). The disposable device can optionally include fluidic elements (e.g., conduits for receiving and delivering the sample to the electrodes or optics), calibrant elements (e.g., fluids for standardizing the electrodes with a known concentration of the analyte), and dyes with known extinction coefficients for standardizing optics. The reading apparatus or instrument contains electrical circuitry and other components for operating the electrodes or optics, making measurements, and doing computations. The reading apparatus can typically display results and communicate those results to a CDS, LIS, and/or an HIS by way of a computer workstation. Communication between a reading apparatus (e.g., a point-of-care device) and a workstation, and/or between a workstation and a CDS/LIS/HIS, may, for example, be by way of an infrared link, a wired connection, a wireless communication, or any other form of data communication capable of transmitting and receiving information, or any combination thereof.
Point-of-care sample testing systems eliminate the time-consuming need to send a sample to a central laboratory for testing. Point-of-care sample testing systems allow a user e.g. a nurse and physician, at the bedside of a patient, to obtain a reliable, quantitative, analytical results, comparable in quality to that which would be obtained in a laboratory. In operation, the user may select a device with the required panel of tests (e.g., electrolytes, metabolites, cardiac markers and the like), draw a sample, dispense it into the device, optionally seal the device, and insert the device into the reading apparatus to communicate the data to an LIS/HIS for analysis. An example of such a system is the i-STAT® system sold by Abbott Point-of-Care, Inc., Princeton, N.J., USA. The i-STAT® portable blood analysis system typically comprises Wi-Fi-enabled reader instruments that work in conjunction with single-use blood testing cartridges that contain sensors for various analytes. For further information on the i-STAT® portable blood analysis system, see http://www.abbottpointofcare.com/.
Analyzers, such as a self-contained disposable sensing device or cartridge and a reader or instrument, are further described in commonly owned U.S. Pat. No. 5,096,669 to Lauks, et al., the entirety of which is incorporated herein by reference. In operation, a fluid sample to be measured is drawn into a device and the device is inserted into the reader through a slotted opening. Data generated from measurements performed by the reader may be output to a display and/or other output device, such as a printer, or, as described in greater detail below, via a wireless network connection. The disposable device may contain sensing arrays and several cavities and conduits that perform sample collection, provide reagents for use in measurement and sensor calibration, and transport fluids to and from the sensors. Optionally, reagents may be mixed into the sample for testing. Sensing arrays in the device measure the specific chemical species in the fluid sample being tested. The electrochemical sensors are exposed to and react with the fluid sample to be measured generating electrical currents and potentials indicative of the measurements being performed. The electrochemical sensors may be constructed dry and when the calibrant fluid flows over the electrochemical sensors, the sensors easily “wet up” and are operational and stable for calibration and composition measurements. These characteristics provide many packaging and storage advantages, including a long shelf life. Each of the sensing arrays may comprise an array of conventional electrical contacts, an array of electrochemical sensors, and circuitry for connecting individual sensors to individual contacts. The electrical signals are communicated to a reader enabled to perform calculations and to display data, such as the concentration of the results of the measurement.
Although the particular order in which the sampling and analytical steps occur may vary between different point-of-care systems and providers, the objective of providing rapid sample test results in close proximity to a patient remains. The reading apparatus (e.g., i-STAT® or other wireless analyzer) may then perform a test cycle (i.e., all the other analytical steps required to perform the tests). Such simplicity gives the physician quicker insight into a patient's physiological status and, by reducing the time for diagnosis, enables a quicker decision by the physician on the appropriate treatment, thus enhancing the likelihood of a successful patient treatment.
In the emergency room and other acute-care locations within a hospital, the types of sample tests required for individual patients can vary widely. Thus, point-of-care systems generally offer a range of disposable devices configured to perform different sample tests, or combinations of such tests. For example, for blood analysis devices, in addition to traditional blood tests, including oxygen, carbon dioxide, pH, potassium, sodium, chloride, hematocrit, glucose, urea, creatinine and calcium, other tests may include, for example, prothrombin time (PT), activated clotting time (ACT), activated partial thromboplastin time (APTT), troponin, creatine kinase MB (CKMB), and lactate. Although devices typically contain between one and ten tests, it will be appreciated by persons of ordinary skill in the art that any number of tests may be contained in a device.
To illustrate examples of the need for different devices, a patient suspected of arrhythmia may require a device with a test combination that includes a potassium test, whereas a patient suspected of diabetes may require a device with a test combination that includes a glucose test. An emergency room will need to have sufficient inventory of both types of devices to ensure the supply meets the anticipated workload, while seeking to limit the economic cost associated with carrying an unnecessarily high inventory. Consequently, efficient communication of inventory status is another reason for implementing a secure wireless connection with the hospital network.
A given hospital may use numerous different types of test devices and test instruments at multiple point-of-care testing locations within the hospital. These locations can include, for example, an emergency room (ER), a critical care unit (CCU), a pediatric intensive care unit (PICU), an intensive care unit (ICU), a renal dialysis unit (RDU), an operating room (OR), a cardiovascular operating room (CVOR), general wards (GW), and the like. Other non-hospital-based locations where medical care is delivered, include, for example, MASH units, nursing homes, and cruise, commercial, and military ships. For all of these, establishing efficient communication between the wireless analyzer/point-of-care device and lab or computer that analyzes the data (e.g., LIS/HIS) via a secure wireless network may be essential.
Thus, in creating and maintaining an environment suitable for point-of-care sample testing (e.g., when a nurse performs sample tests at, or proximate to, the bedside of the patient), many of the forgoing problems associated with delay due to insecure sample transportation to a hospital laboratory for analysis must be eliminated. These problems can be eliminated by implementing secure wireless communication between a wireless analyzer, such as a point-of-care medical instrument, and a hospital network system (e.g., LIS or HIS). In addition, establishing secure wireless communication between a wireless analyzer and a hospital network system is beneficial in maintaining patient confidentiality as well as the confidentiality of associated medical information.
The following patents relating to point-of-care sample testing provide additional background and are incorporated herein by reference in their entireties: DISPOSABLE SENSING DEVICE FOR REAL TIME FLUID ANALYSIS to Lauks, et al., U.S. Pat. No. 5,096,669; WHOLLY MICROFABRICATED BIOSENSORS AND PROCESS FOR THE MANUFACTURE AND USE THEREOF to Cozzette, et al., U.S. Pat. No. 5,200,051; METHOD FOR ANALYTICALLY UTILIZING MICROFABRICATED SENSORS DURING WET-UP to Cozzette, et al., U.S. Pat. No. 5,112,455; SYSTEM, METHOD AND COMPUTER IMPLEMENTED PROCESS FOR ASSAYING COAGULATION IN FLUID SAMPLES to Opalsky, et al., U.S. Pat. No. 6,438,498; MICROFABRICATED APERTURE-BASED SENSOR to Davis, et al., U.S. Pat. No. 6,379,883; APPARATUS FOR ASSAYING VISCOSITY CHANGES IN FLUID SAMPLES AND METHOD OF CONDUCTING SAME to Davis, et al., U.S. Pat. No. 5,447,440; REUSABLE TEST UNIT FOR SIMULATING ELECTROCHEMICAL SENSOR SIGNALS FOR QUALITY ASSURANCE OF PORTABLE BLOOD ANALYZER INSTRUMENTS to Zelin, et al., U.S. Pat. No. 5,124,661; STATIC-FREE INTERROGATING CONNECTOR FOR ELECTRICAL COMPONENTS to Lauks, U.S. Pat. No. 4,954,087; REFERENCE ELECTRODE, METHOD OF MAKING AND METHOD OF USING SAME to Lauks, U.S. Pat. No. 4,933,048; and POINT-OF-CARE INVENTORY MANAGEMENT SYSTEM AND METHOD to Tirinato, et al., U.S. Pat. No. 7,263,501.
Oplasky, et al., U.S. Pat. No. 6,438,498 (the “'498 patent”), describes a computer system optionally including at least one infrared transmitter and/or infrared receiver for either transmitting and/or receiving infrared signals from a point-of-care blood testing instrument. Communications with such external devices—for example, the other components of the system—occur utilizing a communication port. For example, optical fibers and/or electrical cables and/or conductors and/or optical communication (e.g., infrared, and the like) and/or wireless communication (e.g., radio frequency (RF), and the like) can be used as the transport medium between an external device and a communication port. In addition to the standard components of the computer, the computer also optionally includes an infrared transmitter and/or infrared receiver. Infrared transmitters are optionally utilized when the computer system may be used in conjunction with one or more of the processing components/stations that transmits/receives data via infrared signal transmission. Instead of utilizing an infrared transmitter or infrared receiver, the computer system optionally uses a low power radio transmitter and/or a low power radio receiver. The low power radio transmitter transmits the signal for reception by components of the production process and receives signals from the components via the low power radio receiver. However, the '498 patent does not address the issue of establishing a secure Wi-Fi connection to a hospital network. Although infrared technology is still used in modern applications, it suffers from a number of limitations. A first limitation is the inability of an infrared signal to penetrate walls, thus restricting transmission to a single room. A second limitation is that many indoor environments can experience infrared background radiation (e.g., from sunlight and indoor lighting). This background radiation can act as noise to an infrared receiver, necessitating the use of higher power transmitters while further limiting the range.
U.S. Pat. No. 6,845,327 (the “'327 patent”) entitled POINT-OF-CARE IN-VITRO BLOOD ANALYSIS SYSTEM to Lauks describes devices for performing in-vitro diagnostic chemical analyses at multiple distributed locations within a medical institution that involve a wireless network. However, the '327 patent does not address the issue of establishing a secure Wi-Fi connection to a hospital network.
U.S. Pat. No. 7,041,468 (the “'468 patent”) entitled BLOOD GLUCOSE TRACKING APPARATUS AND METHODS to Drucker, et al., describes a measurement module for glucose testing including a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical, removable attachment of the housing to a handheld processing device, handheld computer, PDA, mobile phone, or wireless processing device. Electronics are provided either in the measurement module or in the handheld processing device for determining the amount of glucose present in a sample of body fluid when a test strip is positioned in the receptacle and the fluid is placed on the test strip, and for communicating the glucose amount to the processing device via the connector portion. However, the '468 patent does not address the issue of establishing a secure Wi-Fi connection to a hospital network.
U.S. Pat. No. 7,235,213 (the “'213 patent”) entitled SYSTEM FOR PERFORMING BLOOD COAGULATION ASSAYS AND MEASURING BLOOD CLOTTING TIMES to Mpock, et al., describes a system for performing a blood coagulation assay having (i) a reaction chamber; (ii) at least one movable member configured to mix contents of the reaction chamber; (iii) a sensor configured to detect the presence of a blood clot formed in the reaction chamber; and (iv) a timer that measures an interval of time between when a blood sample is received into the reaction chamber and when the sensor detects the blood clot formed in the reaction chamber. The timer is an instrument that would desirably be able to communicate patient results for a prothrombin time (PT) test securely to a hospital wireless network. However, the '213 patent does not address the issue of establishing a secure Wi-Fi connection to a hospital network.
Two popular types of wireless technology standards available are Bluetooth® and the Institute of Electrical and Electronic Engineering's (IEEE) 802.11 standards (“Wi-Fi”). Bluetooth® is an open specification delivering short-range radio communication between electrical devices that are equipped with Bluetooth® chips. When two Bluetooth®-enabled devices are within communication range (currently about 10 meters), they send each other a unique ID to identify one another. This ID is used to determine the type of information to be shared and the level of functionality that could occur between the two devices. However, Bluetooth® is not designed for long-distance communication, e.g., greater than about 10 meters, but rather as a means for providing connections between mobile computing devices or between a mobile computer device and a hub. To increase operating range, Wi-Fi, which has a larger operating range (currently up to about 300 meters) may be used. Wi-Fi is an extension of the wired Ethernet and uses the same principles as its wired counterpart, thus providing its users with high-speed, reliable connections to a network. Notably, U.S. Pat. No. 5,487,069 entitled WIRELESS LAN to O'Sullivan, et al., the entirety of which is incorporated herein by reference, describes a wireless LAN, a peer-to-peer wireless LAN, a wireless transceiver, and a method of transmitting data, all of which are capable of operating at frequencies in excess of 10 GHz and in multipath transmission environments. In the LANs, the mobile transceivers are each connected to, and powered by, a corresponding portable electronic device with computational ability.
With respect to the establishment of communication with a secure wireless network, it may be typical for the user of a wireless device to enter (e.g., via the combination of a keyboard, display and mouse, touch pad, touch screen, or equivalents) multiple networking parameters (e.g., IP address, network address, network name (also referred to as Service Set Identifier-SSID), and network security settings such as authentication, encryption, network keys and username/password combination) related to the wireless infrastructure and, in certain cases, also download network certificates to the device for authentication purposes.
Unfortunately, the existing methods of connection and authentication requiring input from the user can be both cumbersome and impractical. For example, the number of point-of-care instruments requiring a connection can typically range from 5 to 100 instruments, usually spread over multiple locations within a hospital (ER, ICU, OR, etc). Furthermore, these devices may not include a convenient input mechanism (e.g., a keyboard, actual or virtual, or touch pad). In general, point-of-care blood testing systems (e.g., glucose meters, coagulation meters, and multiple blood testing cartridge instruments) are designed as customized, proprietary devices without general computer features. Thus, the need exists for improved processes for securely networking one or more wireless analyzers to a hospital network without the need for an operator or user to engage in manual initiation steps on or through the analyzers or other instruments.